Kornimate/medical-research-clean huggingface dataset:
trial to compare the routes of administration of an investigational, personalized, therapeutic cancer vaccine oncophage (hsppc-96) in patients with metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the goal of this trial is to determine the safety of hsppc-96 and which route of administration achieves a better response with the vaccine. hsppc-96 is an immunotherapeutic agent made from an individual patient's tumor.

the goal of this trial is to determine the safety of hsppc-96 and which route of administration achieves a better response with the vaccine. hsppc-96 is an immunotherapeutic agent made from an individual patient's tumor. the study is being conducted in houston, texas with patients enrolled into one of two treatment arms. the two treatment arms are either subcutaneous injection or intradermal injection, both with hsppc-96. to be treated with hsppc-96 patients must undergo surgery to remove the kidney tumor and a portion of this tissue will be sent to antigenics' manufacturing facility for processing.

Eligibility criteria:
inclusion criteria: * suspected metastatic renal cell carcinoma (ajcc stage iv) with intact primary tumor * no previous therapy for metastatic renal cell carcinoma * measurable disease (recist criteria) * primary tumor greater than or equal to 7cm on ct or mri * ecog performance status 0-1 * at least 18 years old * life expectancy \> 3 months * adequate cardiac function (nyha i-ii) * not pregnant * provide written informed consent * absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features) * planned complete nephrectomy exclusion criteria: * history of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin a * other cancer (including renal cell carcinoma) within the last five years (with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin) * embolization of the renal artery prior to nephrectomy * active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the principal investigator

Keywords: kidney cancer renal tumor immunotherapy
clinical trial of probiotics in systemic sclerosis associated gastrointestinal disease

Conditions: Systemic Sclerosis

Summary: ssc-associated gastrointestinal (gi) involvement is common, with no effective treatment. probiotics may have beneficial effects on symptoms as supported by one small open-label study (n=10) that demonstrated decreased bloating symptoms in ssc patients after 2 months of probiotics. this study aims to determine (i) whether 60 days of vivomixx probiotics result in greater gi symptom improvement than placebo in ssc outpatients, assessed using an interview-administered 34-item gastrointestinal tract (git) questionnaire and (ii) whether 60 days versus 120 days of probiotics result in greater gi symptom improvement in ssc outpatients, assessed using the git questionnaire.


Eligibility criteria:
inclusion criteria: * ssc that fulfills the american college of rheumatology (acr, 1990) classification criteria or the proposed european league against rheumatism (eular) criteria for very early diagnosis of systemic sclerosis. * ssc overlap syndromes (ie ssc occurring in overlap with other connective tissue diseases) * ssc-associated gi symptoms (heartburn, dysphagia, vomiting, bloating/distension, faecal soilage, diarrhoea, constipation) not due to other causes as determined by clinical evaluation, with a total git score of at least 0.10 * stable doses of immunosuppressive treatment, corticosteroids, and gi medications for 30 days. exclusion criteria: * on anti-biotics or probiotics within the last 30 days * current serious infections requiring hospitalization * long-term indwelling catheter, including patients on total parenteral nutrition * females who are lactating or pregnant
digital outreach intervention for lung cancer screening

Conditions: Lung Cancer

Summary: mpath-lung (mobile patient technology for health - lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. the study will: 1) determine the effect of mpath-lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) elucidate the drivers of patients' screening decisions and screening behavior; and 3) explore implementation outcomes that will impact the sustainability and dissemination of mpath-lung using program data, surveys, and interviews. this project will determine how mpath-lung affects patients' screening decisions and their completion of screening.

primary objective: determine the effectiveness of mpath-lung on receipt of lcs in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, wake forest baptist health and the university of north carolina at chapel hill. secondary objectives: * elucidate the drivers of patients' decisions to receive or forgo lcs through a values clarification exercise embedded within mpath-lung and supplemental semi-structured interviews of at least 50 patients. * assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mpath-lung across diverse primary care settings

Eligibility criteria:
inclusion criteria: * meet the medicare criteria for lung cancer screening, as updated in february 2022: * age 50 - 77 years * smoked at least 20 pack years * current smoker or quit smoking within the past 15 years * be scheduled to see a primary care provider within the health network in the next 3-4 weeks * have a patient portal account or cellphone number listed in the electronic health record exclusion criteria: * patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in english only). * those for whom lung cancer screening would be inappropriate: * prior history of lung cancer * chest ct within the last 12 months * those with medical conditions predicting shorter life expectancy * patients whose home address is not within the state of north carolina. (due to telehealth guidelines)

Keywords: mass screening early detection of cancer digital health interventions decision making, computer assisted
postoperative nausea and vomit in strabismus surgery

Conditions: Strabismus

Summary: postoperative nausea and vomiting (ponv) is a major concern in paediatric inpatient surgery and may increase patient discomfort, delay patient discharge, and increase the cost of patient care. the incidence of ponv after strabismus surgery is relatively high, compared with other inpatient surgeries, particularly in children. oculocardiac reflex (ocr) is a phenomenon defined by bradycardia or dysrhythmia during strabismus surgery. oculocardiac reflex is commonly caused by the traction on the extraocular muscle (eom), which, through the ophthalmic branch of trigeminal nerve, stimulates the vagal center. the afferent arm of the reflex is the ophthalmic branch of the trigeminal nerve, and the efferent arm is the vagus nerve, which diminishes sinoatrial node impulses and leads to bradycardia.while there is a general consensus regarding the role of unmodifiable risk factors for ponv, including the number of muscle and the occurrence of oculocardiac reflex or not, the role of modifiable risk factors, such as duration of surgery and anesthesia and perioperatively administered medications, is still disputed. in the present study, the investigators evaluated whether these factors may be associated with postoperative nausea and vomiting after paediatric strabismus surgery while controlling for a range of covariates.

the primary outcome was incidence of ponv that occurred within 3 days after the operation. the investigators defined ponv as a presence of either nausea or vomiting. in study hospital, it was routine for nurses to assess and record nausea and vomiting every 8 hours for all postoperative patients during postoperative 3 days. accordingly, the investigators retrospectively collected the presence of ponv from electrical medical records. if patients had discharged hospital within postoperative 3 days, the incidence of ponv was assessed solely during hospital stay. the data, collected included information regarding age at surgery, gender, and type of strabismus. during strabismus surgery, the number and sequence of the operated muscles, hr before traction of the eom (baseline hr), maximum decreased hr after traction of the eom, hr at maximum recovery from decreased hr and maintained during traction of the eom (adrenergic hr), and hr at the cutting of the muscle, were collected. oculocardiac reflex was defined as a decrease in hr greater than or equal to 20% rather than maximum at first traction of the muscle.

Eligibility criteria:
inclusion criteria:all patients aged from 2-14 years who underwent strabismus surgery under general anesthesia between january 2018 and november 2018 were included in this study. - exclusion criteria:patients with american society of anesthesiologists (asa) physical status iii or higher. -

Keywords: postoperative nausea and vomiting strabismus surgery oculocardiac reflex
pectopexy autologous vs mesh

Conditions: Uterine Prolapse; Vault Prolapse, Vaginal

Summary: prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse


Eligibility criteria:
inclusion criteria: uterine - vault prolapse - exclusion criteria: * previous vaginal repair for uterine or vaginal prolapse previous suspension procedures for apical prolapse

Keywords: vault uterine prolapse
a trial of the safety and efficacy of k-604 for the treatment of atherosclerosis

Conditions: Atherosclerosis

Summary: the purpose of this study is to evaluate the safety and efficacy of k-604 for the treatment of atherosclerosis.


Eligibility criteria:
inclusion criteria: * moderate carotid artery stenosis exclusion criteria: * history of arteritis * heavily calcified plaque * uncontrolled hypertension * poorly controlled diabetes * hypercholesterolemia

Keywords: atherosclerosis carotid artery disease
patient-reported outcome of facial erythema (proof)

Conditions: Rosacea; Erythema

Summary: the purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). the feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.


Eligibility criteria:
inclusion criteria: * male or female subjects age of 18 years or older * a clinical diagnosis of facial rosacea * a patient self-assessment score of 4 (severe) at baseline prior to the study drug application * a clinician's erythema assessment (cea) score of 3 (moderate) or 4 (severe) at baseline prior to the study drug application exclusion criteria: * more than 5 facial inflammatory lesions (papules or pustules) of rosacea * any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator * known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see investigator's brochure) * female who is pregnant or lactating
study to evaluate esmolol (brevibloc) to manage cardiac function in patients with subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: the purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac function and electrophysiology; to assess the effects of esmolol treatment on serum adrenergic and cardiac biomarkers; to explore the safety of esmolol treatment shortly after subarachnoid hemorrhage (sah). patients will be followed for a maximum of 1 month after the index sah. the primary outcome will be change in systolic function - ejection fraction by simpson's rule (baseline versus day 7 +/- 2 after sah).

subarachnoid hemorrhage (sah) remains one of the most devastating forms of stroke. over 25% of all stroke related potential years of life lost are from sah. outcomes are adversely affected by secondary ischemia from cerebral vasospasm, along with cardiac complications. trials performed in patients with sah have demonstrated benefit after the administration of beta blockers - reducing mortality nearly in half; but concerns over diminishing cerebral perfusion inhibited the widespread adoption of this therapy. our specific aims are as follows: 1. to evaluate the clinical effect of esmolol treatment on cardiac systolic and diastolic function, along with cardiac electrophysiology; 2. to assess the effects of esmolol treatment on serum adrenergic and cardiac biomarkers; 3. to explore the safety of esmolol shortly after sah. the primary outcome will be change in systolic function - ejection fraction by simpson's rule (baseline versus day 7 +/- 2 after sah).

Eligibility criteria:
inclusion criteria: * subarachnoid hemorrhage presumed to be the result of ruptured aneurysm * age 18 years old or greater * able to enroll within 24 hours of onset of symptoms * systolic blood pressure over 140 mm hg or administration of antihypertensives after presentation exclusion criteria: * withdrawal of life support imminent (within six hours) * known heart failure or cardiomyopathy and ejection fraction 35% or below * prisoner or pregnant female * ongoing vasopressor administration to maintain sbp, or clinical suspicion of left ventricular failure * clinically important arrhythmias (history of cardiac arrest or ventricular arrhythmias), conduction abnormalities (mobitz type 2, 3rd degree av block, or symptomatic mobitz 1 without pacemaker), clinical cardiogenic shock, or overt clinical heart failure * active bronchospastic disease (ongoing bronchospasm after sah presentation or current treatment with oral corticosteroids for asthma or obstructive lung disease) * end stage renal disease

Keywords: subarachnoid hemorrhage esmolol cardiac function cardiac electrophysiology
contrast enhanced ultrasound for renal obstruction

Conditions: Kidney; Obstruction; Renal Obstruction

Summary: this research is studying definity ultrasound contrast agent, which is already approved by the food and drug administration (fda) for the ultrasound evaluation of the liver and heart. this research will investigate the ability to use ultrasound imaging with ultrasound contrast agents to evaluate kidney obstruction. eligible participants that are enrolled will have two visits (one before and one after the planned surgery to relieve the kidney obstruction).


Eligibility criteria:
inclusion criteria: * unilateral renal obstruction confirmed by nuclear medicine mag3 dynamic renal scan (diuretic t (time) ½ \>20 minutes) * obstructed kidney with differential function \>15% confirmed by nuclear medicine mercaptoacetyltriglycine (mag3) dynamic renal scan within less or equal (\<=) 6 months from enrollment * patient has elected to move forward with pyeloplasty or proximal ureteroureterostomy to correct the obstruction exclusion criteria: * solitary kidney * any abnormalities of contralateral collecting system (for example (e.g.) hydronephrosis, renal calculi, duplicated collecting system) * known vesicoureteral reflux * ureteral stent in place in the obstructive kidney * patients without a nuclear medicine mag3 dynamic renal scan * previous history of hypersensitivity to ultrasound contrast agents or definity (perflutren lipid microspheres)) * previous sensitivity to polyethylene glycol * pregnant or breastfeeding females * body mass index (bmi) \>=40 without prior ultrasound confirming ability to adequately visualize the kidneys (elevated bmi is known to decrease ability to image the kidneys) * global renal function with a glomerular filtration rate (gfr) \<30 (chronic kidney disease stage 4 \& 5 excluded) * unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, presence of a cardiac shunt)

Keywords: ultrasound imaging ultrasound contrast agents kidney tissue hydronephrosis
sleep quality in healthcare personnel during covid-19

Conditions: COVID-19; Sleep Quality; General Health

Summary: coronavirus disease 2019 (covid-19), represents a medical and psychological challenge to healthcare workers to the limits that it affects their quality of sleep and their general health.


Eligibility criteria:
inclusion criteria: * all healthcare personnel actively working during the pandemic exclusion criteria: * non healthcare workers

Keywords: covid-19 corona virus disease pittsburgh sleep quality index general health questionnare healthcare worker
effects of pitavastatin on lipid profiles in hiv-infected patients with dyslipidemia and receiving atazanavir/ritonavir

Conditions: HIV; Dyslipidemia

Summary: dyslipidemia as a risk factor for cardiovascular disease (cvd) is an increasing problem in hiv-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. pitavastatin is a new hmg-coa reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non hiv-infected individuals. the study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in hiv-infected patients with dyslipidemia and receiving atazanavir/ritonavir. patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. patients were observed for lipid profiles including total cholesterol (tc), triglyceride (tg), low density lipoprotein (ldl) and high density lipoprotein (hdl); and the side effects including clinical and laboratory (serum aspartate aminotransferase (ast), alanine aminotransferase (alt) and creatinine phosphokinase (cpk)). the follow-up visits were every 4 weeks until the end of the study.


Eligibility criteria:
inclusion criteria: * aged ≥18 years * able to provide informed consent * had confirmed hiv infection * on art including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization * patients who had cholesterol level between 200 and 500 and ldl between 130 and 400 mg/dl without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization exclusion criteria: * had the history of pitavastatin and/or the constituent of the drugs allergy * known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment * abnormal ast and alt with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (unl) in symptomatic patients * pregnancy or breastfeeding * on cyclosporine which had major drug interactions with pitavastatin * patients who denied to join the study

Keywords: hiv-infected patients with dyslipidemia and receiving atazanavir/ritonavir
study on continuous intravenous of unfractionated heparin (ufh) to treat progressive cerebral infarction

Conditions: Heparin Causing Adverse Effects in Therapeutic Use; Heparin-induced Thrombosis; Acute Cerebral Ischemia

Summary: a clinical trial to study the effects of dosage, infusion methods and complications of unfractionated heparin (ufh) treating acute progressive cerebral infraction was conducted. in this study, we observed the effects of four ufh treatments on 480 acute progressive cerebral infraction patients during from the 6th and the 72nd hour after the attack. it was concluded that the ultra-slow continuous intravenous infusion of ufh can significantly reduce the neurological deficit score of patients with progressive cerebral infarction, increase the cure rate, decrease the recurrence rate, and improve long-term quality of daily life. it is more effective than the treatment of intravenous infusion of low- molecular- weight ufh at once a day, and the risk of bleeding may not necessarily be increased.

treatment' effectiveness rates of the four groups were 95.80%, 85.22%, 85.47%, and 87.72% respectively. the result of group a was significantly different from those of group b, c, and d (p \<0.05). the adverse complication occurrence rates of the four groups were 5.88%, 3.48%, 4.27% and 3.51%.

Eligibility criteria:
inclusion criteria: * time after breakout: 6- 72 hours * blood pressure: below 180/100 mm hg (1 mm hg= 0.133 kpa) * paralyzed limb muscle strength: level 0 * being conscious or in mild or moderate coma, and hernia- free * the nerve function continued to aggravate from several hours to a week after the breakout. * no abnormal blood coagulation platelet count plt \>10×109/l * brain ct or mri confirming and ruling out the occurrence of bleeding * match the diagnostic standards of acute cerebral infraction established by the 4th chinese china neurology association * informed consent agreement signed exclusion criteria: * history of intracranial hemorrhage bleeding risk or plt \<10 × 109/ l * record of severe heart, liver, or renal insufficiency or severe diabetes mellitus * infarct area larger than 1/3 of hemispheric area * pregnant
pharmacokinetics and pharmacodynamics of oral sertraline before and after bariatric surgery

Conditions: Overweight; Depression; Anxiety Disorders

Summary: volunteers with a prescription of oral sertraline who have been scheduled to bariatric surgery in either norrköping/sweden or lindesberg/sweden will be asked to participate in a observational study. the aim of this study is to evaluate the absorption and the effect and side effects of sertraline in volunteers 8 weeks before and 1, 6 and 12 months after bariatric surgery.

the pharmacokinetic changes of sertraline after bariatric surgery are studied by assessing the exposition for sertraline in individuals with long term treatment by measuring the area under the curve (auc0-τ) 8 weeks before and one, six and twelve months after bariatric surgery in 30 participants. the effect of variation of sertraline concentration is studied by a psychiatric assessment of depressive symptoms and symptoms of anxiety disorder. the aim ist to study if there is a relation between changes in pharmacokinetics and effect of sertraline after bariatric surgery. for the assessment of side effects a self-reporting scale is used. these participants are recruited consequentially with the aim to get equal numbers of patients with both most usual types of surgery in sweden (laparoscopic rygb and gastric sleeve).

Eligibility criteria:
inclusion criteria: * scheduled to undergo either gastric bypass or gastric sleeve surgery via surgeon clinics in örebro or norrköping * prescription of sertraline * since at least one month * planned to be continued at the time of inclusion * swedish speaking exclusion criteria: * comorbidity with the consequence that the potential participant may not be able to complete the study * if participation should result in a high risk for patients health or safety

Keywords: pharmacokinetics pharmacodynamics